FDA.reportPublic FDA data

Formoterol Fumarate Inhalation Solution

Product NDC
76204-030
11-digit product format
762040030
Labeler code
76204
Product ID
76204-030_459f276c-d771-4ae9-e063-6394a90a3476
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
Application
ANDA216486
Marketing category
ANDA
Marketing start
2025-03-14
Substance
FORMOTEROL FUMARATE
Active strength
20 ug/2mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Formoterol Fumarate Inhalation Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FORMOTEROL FUMARATE20 ug/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW34SHF8J2K
Rxcui1246319

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76204-030-01Formoterol Fumarate Inhalation Solution1 in 1 POUCHSOLUTION13
76204-030-01Formoterol Fumarate Inhalation Solution30 in 1 CARTONSOLUTION303
76204-030-02Formoterol Fumarate Inhalation Solution60 in 1 CARTONSOLUTION603
76204-030-02Formoterol Fumarate Inhalation Solution1 in 1 POUCHSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-030-01ML - Milliliter76204-0307c72c522-0b8f-4caa-b054-2a07e38d1e3312025-05-14
76204-030-02ML - Milliliter76204-0307681015e-c4df-4a55-8eb1-1ecf004ef8a412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-030FORMOTEROL FUMARATE INHALATION SOLUTION (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]2Current NDC, 4 package rows20250315_2d9bf685-8886-4865-834b-2748af124b79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN2d9bf685-8886-4865-834b-2748af124b793
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD2d9bf685-8886-4865-834b-2748af124b793
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY2d9bf685-8886-4865-834b-2748af124b793
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY2d9bf685-8886-4865-834b-2748af124b793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76204-030-017620400300130 POUCH in 1 CARTON (76204-030-01) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL30 pouch2025-03-14NoNoHistorical
76204-030-027620400300260 POUCH in 1 CARTON (76204-030-02) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL60 pouch2025-03-14NoNoHistorical